Bone cleaning tool

ABSTRACT

The present invention is directed to systems, methods, tools and surgical procedures that provide for improved, faster and/or more efficient methods for cleaning bone of soft tissue in preparation for use in bone grafting and surgery, including specific applications particularly useful in fusion procedures and/or other surgeries of the lumbar, cervical, and/or thoracic spine and/or other anatomical locations, desirably allowing for faster and complete healing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/973,483, entitled “Bone Cleaning Tool,” filed May 7, 2018,which is a continuation of U.S. patent application Ser. No. 14/704,616,entitled “Bone Cleaning Tool,” filed May 5, 2015, which claims priorityfrom U.S. Provisional Patent Application No. 61/988,818 filed May 5,2014, entitled “Bone Cleaning Drill Bit,” the contents of which are eachhereby incorporated herein by reference in their entireties.

TECHNICAL FIELD OF INVENTION

The invention relates to systems, methods, tools and surgical proceduresfor denuding bone for bone bed preparation and/or preparing autograftbone for bone graft implantation into the body during bone graftingsurgery, which can be used in a variety of anatomical locations within apatient. In various embodiments, the disclosed bone cleaning tool andrelated methods of use can be particularly useful in specificapplications such as bone grafting and/or fusion surgery, includingspinal fusion procedures and/or other surgery of the lumbar, cervical,and/or thoracic spine.

BACKGROUND OF THE INVENTION

During the course of spine fusion surgery, bone from spinous processes,laminae, facets and/or iliac crest are removed from a patient and areoften reimplanted as autograft in increasingly numerous ways, typicallyto promote fusion of or other repairs to the patient's bones. In orderto achieve bone fusion or osteogenesis, there will desirably be a boneto bone contact surface between the host bone and the bone graft. Toachieve such a contact surface, soft tissue normally found on bone, suchas periosteum, tendon, muscle, ligament and fibrous tissue will beremoved from the contact point of both the host and graft bone. It hasbeen well documented in the clinical literature that that interveningsoft tissue hinders, if not totally prevents the connection of bonecells. Such impedance or prevention of the passage of the bone cells maycause the fusion procedure to fail thereby resulting in a negativeimpact on the health of the patient. One well known complication ofspine fusion surgery is pseudoarthrosis, which can occur when apatient's vertebral segments fail to fuse together in a desired manner,often leading to back pain, instability, and need for further surgery.Even if a given fusion procedure is successful, the process may take ayear or more for completion, and during this time (or for varyingperiods afterwards) the patient often experiences resultant pain anddisability. There are many expensive methods, devices, biologics, andallografts currently commercially available that claim to improve therate and/or quality of fusion in a surgical procedure.

Autologous bone graft refers to the removal of bone from one location ina patient and subsequently placed in the same and/or another location inthe same patient. This type of bone graft is commonly called anautograft, and one major factor contributing to a successful and rapidfusion using autograft is “bone quality.” The quality of bone that isprepared, removed, processed and reimplanted as autograft is oftenhighly dependent on the techniques and experience of an individualsurgeon, as well as the surgical technologist's skill level. Before bonecan be reimplanted into a patient, the surgeon or surgical technologistwill desirably clean the bone of connective tissues, and prepare thebone for fusion in various ways. Current methods of cleaning of the boneprior to reimplantation can include manually scraping the bone withvarious periosteal elevators, curettes, rongeurs, cautery tools andother multi-purpose tools. Typically, the muscles are stripped away fromthe bone using cautery and Cobb elevators. Soft tissue is partiallyremoved with large rongeurs, and various portions of the bone arecuretted. Depending upon the type of surgical procedure and type ofsurgical access (i.e., open, less-invasive and/or minimally-invasiveapproach paths), the spinous processes may be cut and the cut bone givento an assistant or technologist. Similarly, laminae and/or facets can bedrilled (often with significant loss of bone stock) and may berongeured, with small bone pieces given to the technologist, who mayproceed to use fine rongeurs to remove any remaining soft tissue fromthe saved bone. This type of bone preparation and cleaning can be atedious and time-consuming process. Prior to reimplantation, theharvested bone is then cut into small pieces, either manually withrongeurs, or mechanically (i.e., with a bone mill).

In many cases, the current bone cleaning process is often, tedious,difficult, incomplete, and/or time consuming resulting in (1) incompleteor inadequate bone graft preparation that may lead to delayed andinadequate fusion or healing, (2) incomplete or inadequate bone bedpreparation that may lead to delayed and inadequate fusion or healing,(3) the use of undesirable bone graft, especially where it incorporatesand/or is utilized with attached small tissue, (4) the discarding ofgood bone stock because it is difficult or impossible to separate fromassociated soft tissue, (5) an increase in the occurrence ofpseudoarthrosis, or (6) failure of the surgical procedure. In all cases,these results may be suboptimal.

To compound the existing problems described above, the surgeons and/orsurgical technologists typically use a combination of general purpose orvarious other cutting tools to prepare and remove autograft tissues. Thetools that are typically used can include general multi-purpose toolsthat may be designed for proper bone removal, but are not intendedand/or well suited to remove soft tissue. Such general multi-purposetools can include rongeurs, curettes, periosteal elevators, drill bits,burrs and other tools. For example, currently used drill bits and burrscould be used to clean bone, but these are designed to cut, ream, orgrind away bone, and are not typically intended to remove soft tissueswhile maintaining optimal fusion bone yield. Using generalizedmulti-purpose tools to prepare and remove the autograft can yield a widevariety of disadvantages, including (1) low autograft bone yield, (2)disposal of bone autograft because the bone graft may be too stronglyattached to connective tissue for adequate or timely removal for theoperation, (3) poor tool strength and material/bone build-up because itmay not be used for its intended purpose, (4) multiple tool exchanges(and additional time for the surgeon) be may be required to accomplishpreparation of a given anatomical structure of the patient, (5) lossand/or contamination of useable bone material where tool linkages,lubricants and/or coolants prevent collection and utilization of removedmaterial, (6) difficulty in collecting removed bone material fromcutting surfaces and/or tool voids, and/or (7) loss of bone frommishandling during the course of cleaning the bone.

Pre-existing devices for denuding, decorticating and shaping bonegenerally incorporated one of six basic design elements; fluted boneburrs, saw blades with various tooth configurations, bone cuttingrongeurs, scalpels, cautery devices and wire-bristle type brushes. Whilesome such instruments have been used to remove soft tissue and shapebone, each is functionally limited in providing an effective means toremove soft tissue from bone.

As an example of prior art, bone burrs have been commonly used todecorticate autografts and allografts. However, to remove soft tissuefrom bone, bone burrs require significant force and high speed rotationof the burr. The force applied, as well as the high speed rotation ofthe burr, typically generates heat at the contact point where the burris placed on the bone. Such heat increases the potential for the onsetof thermal necrosis. Additionally, such prior art devices commonlyrequire the application of water during its use to reduce the heatbuild-up. The use of water can significantly decrease the visibilitywithin the operative area and thereby creates a potential surgicalproblem.

An earlier prior art device, the bone saw blade, was designed to cutbone in a straight line. Though the saw blade can effectively cut bone,it is ineffective and impractical to use a saw blade to remove layers ofsoft tissue from bone, as the saw is typically unable to differentiatebetween the types of tissue(s) it is cutting. Attempts at such removalgenerally resulted in loss of bone stock and very little removal of thesoft tissue. Further, the use of saw blades does not provide a means toeasily contour round bone or bone grafts.

An example of a prior art manual instrument device is represented by thebone cutting rongeur. This instrument can be used to remove soft tissuefrom bone and has been used for this purpose. Such use however, requiresthat the jaws of the device bite into the bone itself and therebytypically remove bone material in the process of removing soft tissue.The use of such a device is both time consuming and ineffective whensmall autograft or allograft are being used, and it is difficult tofollow the contours or curved surfaces with rongeurs. Additionally, whenbone cutting rongeurs are used, the volume of bone loss is significantlyhigher than with the current invention.

While not designed for use as a soft tissue removal device, theelectro-cautery device can remove soft tissue as it effectively burnssoft tissue away from bone. However, this device creates a significantamount of heat at the contact point of the cautery tip on the bone. Suchlarge amounts of heat generation increase the potential of terminalnecrosis at the bone contact point. Prior art devices used to removesoft tissue, decorticate and or shape bone, do not allow sufficientcontrol of the amount of soft tissue removed as compared to the amountof bone removed or the device creates significant heat at thebone/device interface, thereby increasing the potential for a negativeclinical result.

Another prior art device for soft tissue removal includes a wire-bristletype rotary cutter, such as disclosed in U.S. Pat. No. 5,733,288, thedisclosure of which is incorporated herein by reference in its entirety.While wire-bristle rotary cutters are disclosed as being capable ofseparating soft tissue from underlying bone, the wire bristles willoften very quickly fatigue and fracture in contact with the underlyingbone surface, potentially ejecting the fractured wire outward in amanner which makes such brushes highly undesirable for use in surgicalprocedures. Moreover, the bristles can also easily remove hard and/orbony tissues in an indiscriminate manner, which is undesired in manyinstances. In addition, the high rotational speed of wire-bristle rotarycutters can easily generate excessive heat on the bone surface, and thisrotation further typically renders such devices incapable of retainingany significant amount of morselized tissue and/or bone fragments, asthe centrifugal force generated by such rotation will throw suchfragments outward of the wire-bristle fibers.

As a result, an improved specialized tool may be desirable for surgeonsand/or surgical technologists for autograft preparation and boneremoval, allowing for efficient and effective removal of soft tissue(s)from host bone without removing significant quantities of the bone stockitself.

SUMMARY OF THE INVENTION

In various embodiments, a bone and soft tissue drill bit and/or tool(i.e., a bone cleaning rotary tool or “bone cleaning tool”) may be usedindividually (as a single tool) and/or as an attachment to acommercially available high-speed surgical drill or custom high speedsurgical drill. The commercial surgical drill may be of a type normallyused in the surgical theatre, which reduces the need for additionalequipment in the operating room. Furthermore, the head of the “bonecleaning tool” may incorporate into its design various biocompatiblematerials of differing shapes and dimensions such that, when applied tosoft tissue connected to bone, the soft tissue can be removed in adesired manner and/or at a desired rate thoroughly while leaving thebone substantially intact. In various embodiments, disclosed devices andmethods can facilitate the removal of soft tissue from human bone (1)without excessive heating of the bone, (2) without removal ofsignificant amounts of the bone stock, and (3) in a significantlydecreased time and improved efficiency as compared to othercurrently-available devices for preparing allograft bone and/or bonebeds.

In various exemplary embodiments, the bone cleaning tool may be used insitu, prior to removal of the bone from the harvest site. Byfacilitating the separation and/or cleaning of bone from other softtissues in situ, which can be desirably accomplished while the bone isstill attached in an original position within the patient anatomy (wheredesired), the intact bone is desirably well-anchored to the anatomicalsite (reducing and/or obviating the need to hold or otherwise secure thebone during the preparation procedure), and the intact bone portion thatis eventually removed from the patient can be substantially and/orcompletely “cleared” of any soft tissues, such that the surgeon ortechnologist does not need to spend effort and time to clean the bone,as well as assist with the handling of smaller-sized bone graft pieces.In this manner, the various tools and techniques described herein canresult in better quality fusion bone, and higher fusion bone yield bysignificantly reducing disposal of good bone stock simply because it isattached to soft tissue structures that are difficult or impossible toremove.

In some embodiments, an improved bone cleaning tool may be provided witha guard or other features to inhibit removal of certain anatomicalfeatures and/or tissue types. In one embodiment, a guard may bepositioned over the head and/or shaft of the bone cleaning tool tominimize airborne debris from use of a high-speed drill.

In various other alternative embodiments, an improved bone cleaning toolor other surgical tool may be designed to incorporate a double or triplehelix flute configuration. The double or triple helix flute bonecleaning tool may be desirous for a wide variety of reasons, which couldinclude advantages due to increased tool strength, or the tool mayincorporate a fewer or greater number, shape, thickness and/or length oftubular projections, spines or other protrusions to remove soft tissue,and/or the bone cleaning tool may incorporate design features that canprovide a unique pathway and/or debris retention feature(s) for boneand/or soft tissue material egress and/or containment/storage.

In various embodiments, a double or triple helix flute design mayinclude specialized cutting surfaces, shapes, channels, and/orconfigurations that may provide a variety of features, includingimprovements in flute strength and/or cutting capabilities. For example,one embodiment incorporating a double or triple helix flute design mayinclude a gutter, channel and/or trench where a plurality of spines maybe placed in various locations throughout the flutes to prevent and/orreduce any yielding and/or rotation of the material, avoid deflection ofthe spines and/or direct collection of removed material in a desiredmanner. In various embodiments, one or more surfaces of one or morehelixes may include a cutting or abrading surface on a leading ortrailing edge of the helical surface, which may be in addition to thevarious spined surfaces described herein.

In other alternative embodiments, an improved bone cleaning tool mayinclude design features such as spines and/or protrusions (orindentations, in other embodiment) that may include a plurality ofshapes and/or configurations. The shapes and configurations of thespines may be short, long, wide, triangular, square, spherical, curved,rounded, and/or a combination thereof. Such a variety and/or pluralityof shapes and/or configurations may be desirable based on whether thesurgeon and/or surgeon technologist may want gross and/or fine softtissue and/or bone removal, and/or to increase and/or decrease“splatter” for various reasons. In addition the plurality of shapesand/or configurations may be positioned on the surface of the bonecleaning tool uniformly or non-uniformly.

In various other alternative embodiments, an improved bone cleaning toolmay be provided with spines or other features that may includeindependent bone cutting surfaces on one of more of the spine or otherfeature surfaces. The cutting surfaces may be designed with a pluralityof shapes and configurations to accommodate the type of cutting desiredby the surgeon and/or surgeon technologists, and selective activation ofsuch cutting surfaces may be accomplished by a variety of techniques,including by reorienting of the bone cleaning tool and/or cuttingsurfaces relative to the soft tissue/bone and/or reversing rotation ofthe drill or other actuating tool attached to the bone cleaning tool.Such shapes and configurations of the cutting surfaces may includeshapes or configurations that may allow and/or facilitate the grasping,pinching, cutting and/or severing of a specific type of target softtissue and/or bone material there between. Furthermore, the shapesand/or configurations of the cutting surfaces may also have sharpened,beveled, and/or tapered cutting surfaces to sever, cut and/or grind thespecific targeted bone or soft tissue, and/or accomplish whatever grossand/or fine cutting may be desired.

In various other alternative embodiments, an improved bone cleaning toolmay be designed with spines including a variety of flexible ornon-flexible materials, or various combinations thereof. Desirably, thespines can incorporate a plurality of surfaces that, when orientationand/or rotation of the bone cleaning tool is altered (i.e., by reversingthe drill, for example), present a different cutting and/or abradingfeature to the tissue(s) of interest. For example, a bone cleaning toolmay be constructed that removes soft tissue from underlying bone in aforward direction, but which cuts, shapes and/or removes bone whenoperated in a reverse direction. Similarly, a bone cleaning tool may beconstructed that removes gross amounts of soft tissue from underlyingbone in a forward direction, but which cuts, shapes and/or removeslesser amounts of soft tissue from underlying bone when operated in areverse direction.

In other alternative embodiments, an improved bone cleaning tool may bedesigned with different shapes and configurations to access variousspacing, including small spaces up to large spaces, and/or differentcontoured bone surfaces. For example, the improved bone cleaning toolmay be conically shaped allowing the surgeon and/or surgeon technologistto use the tip of the improved bone cleaning tool to access small spacesand/or under edges or create shapes or channels, which may includedifferent cutting and/or shaping surfaces on the conical section ascompared to other section(s) of the bone cleaning tool. The surgeonand/or surgeon technologist may advance the conically shaped bonecleaning tool portion to access larger spaces with the larger diameter,which may incorporate lesser or greater cutting features, if desired.Furthermore, the radiused perimeter may be designed to access, cut,grind, or smooth contoured bone and/or soft tissue, should it bedesired.

In other alternative embodiments, an improved bone cleaning tool may bedesigned to include a plurality of apertures. The plurality of aperturesmay be positioned uniformly, non-uniformly, symmetrically,non-symmetrically, recessed from the outer diameter, raised from theouter diameter, and/or may have cutting edges on an outer, medial and/orinner surface(s), which may include an abrading surface on an outersurface of the tool (i.e., between apertures). In various embodiments,one or more apertures could include one or more outwardly extendingcutting surfaces, in a manner similar to the cutting surfaces withinapertures of a cheese grate or microplane. In various embodiments, thecutting edges/surfaces could be contained within the apertures and/orrecessed inside or and/or below the apertures, if desired. In variousembodiments, two or more cutting surfaces having differing shapes, sizesand/or modes of cutting action could be incorporated into a singleindividual aperture.

In other alternative embodiments, the improved bone cleaning tool may beavailable as separate and individual tools, and/or multiple sizes and/orconfigurations of tools may be provided in a kit. If the improved bonecleaning tool is available as separate and individual tools, the surgeonmay request the type of tool that will be specialized for thepreparation, removal and/or reimplantation of the autograft.Alternatively, if a plurality of improved bone cleaning tools may beprovided in a kit, the kit may include a variety of the designsspecialized for the desired cutting (fine or gross), grinding, severing,smoothing and/or other actions desired by the surgeon and/or surgeontechnologist.

In other alternative embodiments, an improved bone cleaning tool may beused for a variety of other surgical applications that may include thepreparation of bone or other anatomical tissues. For example, thesurgical application that may be desired may be a procedure performed toprepare vertebral body endplates for interbody fusions. By removing softtissue without cutting or grinding cortical bone and/or penetratingcancellous bone, the vertebral endplates may be preserved, which cangreatly reduce the chance for interbody cage or graft subsidence, aknown complication of such surgery. If desired, one embodiment of adevice could be designed such that, when operated in a first directionit facilitates in situ bone cleaning of the lamina, facets and spinousprocess(es), and in a second direction facilitates cleaning of thevertebral endplates for preparation of an interbody graft.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an isometric view of one embodiment of a bone cleaningtool with extended spines;

FIG. 2 depicts an isometric view of one embodiment of a bone cleaningtool with low-profile spines;

FIG. 3 depicts an isometric view of one embodiment of a bone cleaningtool with apertures;

FIGS. 4A-4B depict various exemplary views of one embodiment of a bonecleaning tool with micro-curette surfaces;

FIGS. 5A-5C depict various exemplary views of one embodiment of a bonecleaning tool with a triple helix flute;

FIGS. 6A-6C depict various exemplary views of one embodiment of a bonecleaning tool with spherical helix flute;

FIGS. 7A through 7E depict various views of another exemplary embodimentof a bone cleaning tool with apertures; and

FIGS. 8A and 8B depict perspective views of another exemplary embodimentof a bone cleaning tool with apertures.

DETAILED DESCRIPTION OF THE INVENTION

In various embodiments, a “bone cleaning tool” or other cuttingstructure can be designed to include features that may also leverage asurgical drill's bidirectional features, including cutting features on a“reverse” surface of the structure, as well as surfaces that cut orotherwise perform differently depending upon whether the drill isoperated in the forward or reverse directions and/or at a specific anglerelative to the work piece, which are features that are not utilized bymany currently-available drill bits and burrs. In various alternativeembodiments, the bone cleaning tool may be reversible, where the bonecleaning tool operating in either direction allows the cutting,severing, smoothing action, and/or combination thereof of soft tissueand/or bone when desired, which may include similar and/or differingcutting types and/or features when operating in opposing directions(i.e., forward and reverse).

In various embodiments, feature(s) may be provided that allow the bonecleaning tool to collect and/or retain morselized tissues when operatedin a forward direction, but which does not collect and/or retain suchmorselized tissues in the reverse direction. Such an arrangement may beparticularly useful to a surgeon that is removing soft tissues byoperating the tool in the forward direction, and then reversing thedrill and using the bone cleaning tool in a reverse direction tomorselize bone and/or collect autograft bone for subsequentreimplantation. If desired, such an embodiment could potentially ejectand/or release such morselized tissues when operated in a directionopposite to the collection and/or retention direction, which couldinclude collection of such morselized tissues by placing the bonecleaning tool within a container or cup and then operating the tool inthe “release” direction, desirably contacting or “splattering” theinside surface of the cup with the collected tissues and potentiallycleaning the bone cleaning tool at the same time.

FIG. 1 shows one exemplary embodiment of a simple bone cleaning toolhead 10 with extended spines 20 and a conical tip to allow access tosmall and large surfaces. The extended spines may be oriented uniformly,non-uniformly, symmetrical and/or non-symmetrically on the surface ofthe bone cleaning tool head. In addition, the extended spines may extendorthogonally, perpendicularly, and/or diagonally from the surface of thebone cleaning tool head, which could include spines that are aligned atone or more orientations ranging from parallel to the longitudinal axisof the support shaft up to perpendicular to the longitudinal axis of thesupport shaft (i.e., including spines oriented at approximately 0°, 15°,30°, 45°, 60°, 75° and/or 90° from the longitudinal axis of the supportshaft)—see FIG. 1. Furthermore, the extended spines may have varyinglengths along the surface of the bone cleaning tool head.

In various aspects of the invention, the spines 10 can be attached toand/or formed integrally with the bone cleaning tool head assembly 10.As best seen in FIG. 1, a conical tip 30 of the head 10 can include aplurality of spines which are each aligned approximately perpendicularto a local surface of the curving head, which due to the curvature ofthe head create a region of non-parallel spines extending outward fromthe head at the tip 30. Desirably, spines in the tip region can beutilized to cut and/or prepare tissues and/or bone in confined and/or“tight” spaces, with other spines of the head utilized to cut and/orsmooth larger portions of the tissues. If desired, some or all of thespines of the tip region could include the same and/or different cuttingfeatures than spines of the more flattened region of the head.

The head assembly can be of various diameters and shapes that providefor optional surgical uses. The various components of the bone cleaningtool, including the head assembly, spines and/or solid shaft, can bemanufactured from surgical grade stainless steel or other knownmaterials acceptable for use and/or implantation in the human body.Individuals knowledgeable in the art are aware of a variety of materialssuch as composites, titanium, nitinol, and other alloys which can beused in the manufacture of the current invention.

If desired, the head 10 can be formed from a rigid material, with thespines rigidly fixed to the head, or in alternative embodiments the headcould comprise one or more flexible and/or deformable materials, suchthat the spines could displace and/or flex relative to the head and/oreach other during use of the tool. In other alternative embodiments, oneor more of the spines may be flexibly attached to a solid and/orflexible head, which could include flexible attachment that allowsmovement of the spines without allowing for significant rotation of eachspine relative to the head, or which allows free rotation of the spinesrelative to the head but not significant flexing of the spines relativeto the head, and/or various combinations thereof. In variousembodiments, the spines could be substantially rigid and/or flexible,and could comprise rigid and/or flexible materials and/or combinationthereof. If desired, some spines could be flexible and/or flexiblyattached, while other spines are rigid and/or rigidly attached to thehead, or various combinations thereof.

In the present invention, the bone cleaning tool can include a solidshaft 40 in a plurality of lengths and/or diameters, with the cuttinghead 10 firmly attached at one end of the shaft. The solid shaft isprovided as an interface for inserting the bone cleaning tool orinstrument into a surgical rotary hand piece or drill (not shown). Thesurgical hand piece can be pneumatic, battery or electrically powered,and can provide rotary action, at variable speeds and/or directions, incompliance with the various application methods described herein.Alternatively, a reciprocating or oscillating hand piece (not shown),which could operate in a manner similar to a surgical saw or “saws-all”powered tool (or other type surgical tool), could be utilized with thevarious embodiments described herein, if desired.

The bone cleaning tool head assembly is desirably firmly attached to theshaft, such that it will rotate at the same revolutions per minute asthat of the shaft. When the invention is inserted into a surgical rotaryhand piece and the revolutions per minute selected, the bone cleaningtool will desirably rotate at the selected speed. At least one objectiveof the current invention is that, when the spines of the tool are placedinto contact with the soft tissue covering the bone, at least onecutting surface on the spines contact the soft tissue and remove thesoft tissue from the surface of the bone without significantly damagingand/or removing the underlying bone.

In at least one embodiment, the bone cleaning tool, after being attachedto a surgical rotary hand piece, can be rotated in a circular manner andapplied to the soft tissue covering of bone in a back and forth manner,thereby removing the soft tissue from the bone.

FIGS. 2 and 3 show exemplary alternative embodiments of bone cleaningtools 100 and 200 incorporating reaming and/or cutting heads that can beutilized to cut out and/or abrade different types and manners of softand/or hard tissues. The reaming and/or cutting heads 100 and 200 maycontain features that facilitate the removal of soft tissue in situ,prior to removal of the bone and potentially preserve and/or preventdamage to remaining bone harvest site area. These features may includetextured bone cleaning tool head surfaces including raised protrusions110 and/or a plurality of apertures 210 placed into and/or on thesurface of the reaming and/or bone cleaning tool head. The plurality ofapertures 210 and/or raised protrusions 110 may contain one or morecutting surfaces and/or edges in at least one area within and/orsurrounding the perimeter of the aperture. For example, an exemplaryaperture could include a steeply inclined cutting surface (not shown)formed along one portion of an internal wall (which would desirably cuttissue in a given manner while the tool was rotated in a firstdirection), and a less-steeply inclined cutting surface (not shown)formed along a second portion of the same internal wall (which woulddesirably cut tissue in a different manner while the tool was rotated ina second direction). If desired, a first cutting surface couldincorporate a more-aggressive cutting surface than the second cuttingsurface, and/or the first cutting surface could incorporate an edge orcontacting surface designed to cut, abrade and/or morselize one type oftissue (i.e., bone) while the second cutting surface could incorporatean edge or contacting surface designed to cut, abrade and/or morselize asecond type of tissue (i.e., soft tissue). As used herein, amore-aggressive cutting surface can include surfaces having a sharperedge, a more inclined cutting surface, or some other feature(s) thatdesirably increases the ability of the more-aggressive cutting surfaceto cut, abrade and/or morselize a certain type of tissue as compared toanother cutting surface type. If desired, the plurality of apertures,textured bone cleaning tool head surface and/or raised protrusions mayhave similar or different sizes, shapes, cutting edges/features and/orconfigurations.

If desired, one alternative embodiment of a bone cleaning tool couldinclude three or more cutting surfaces on each spine and/or within eachaperture, with a first cutting surface incorporating a less-aggressivecutting surface for use in a forward rotary direction of the tool, asecond cutting surface incorporating a more-aggressive cutting surfacefor use in a reverse rotary direction of the tool, and a third cuttingsurface incorporating a most-aggressive cutting surface designed for usein a linear, non-rotary manner (i.e., forward planar motion and/orreciprocating back-and-forth motion of the head). If desired, a fourthcutting surface could be further incorporated, such that thereciprocating motion could cut, abrade and/or saw tissue in bothback-and-forth directions. Such a tool could be utilized by a surgeon toprepare tissues and/or bone, with different cutting actions performedduring (1) forward rotation, (2) reverse rotation and/or (3) linearand/or reciprocating motion of the non-rotating tool, potentiallyobviating the need for tool exchanges during bone and/or tissuepreparation.

FIGS. 4A and 4B show another alternative embodiment of a bone cleaningtool 300 with spines 310 having spine tips 320 having one or morecutting edges, which in this embodiment are shaped as micro-curettes fora more aggressive scraping force. The micro-curettes can be aligned invarious positions and angles to allow for complete soft tissue removaland for using the bidirectional feature of the high-speed drill (i.e.,reversibility) for differential cutting/shaping and/or materialretention. For example, the spines may be shaped or configured to allowcutting and/or severing of bone or soft tissue in one direction, andwhen the drill is placed in the reverse direction, the adjacent surfaceof the spines (and/or the cutting surfaces of opposing-directed spines)may allow grinding and/or smoothing of the bone surface and/or mayinclude an undercut section or void for retention of cut/shapedmaterials.

FIGS. 5A-5C and 6A-6C show two additional exemplary embodiments of bonecleaning tools 400 and 500 comprising drill bit heads with various“directional cutter” surfaces and/or spines or other protrusions at thehead. In these embodiments, the bone cleaning tools can include spinesand a helical design with flutes to facilitate egress of soft tissue.The bone cleaning tool head can also include blades which can allow foruser-controlled aggressive removal of tougher, more adherent tissue,which may be actuated in a variety of ways, such as by potentiallyengaging the bone cleaning tool in the reverse direction, so as to allowthe cutting surfaces to cut differing amounts and/or types of tissue ascompared to the less aggressive “forward” spine direction. In oneexemplary embodiment, the spines could be utilized to remove and/orprepare the softer tissues surrounding the bone, while the cuttingsurfaces and/or blades could be utilized to remove and/or cut the bone,if desired. The bone cleaning tool head may include various shapes,configurations and dimensions to accommodate the size of the bone and/orsoft tissue being removed.

FIG. 7A depicts a perspective view of another exemplary embodiment of abone cleaning tool 700. The tool 700 includes a drive shaft 705 with acutting head 710 mounted thereto. As can be best seen in FIG. 7D, theshaft is secured to the cutting head via a plurality of axial supports715, with three supports 715 depicted in the disclosed embodiment,wherein differing numbers and/or arrangements of supports, such as 2, 4,5 or 6 supports (or others) can be utilized, if desired. Desirably, thesupports 715 can be configured to create one or more openings 720between the shaft 705 and the cutting head 710, to allow cut and/orabraded material to enter the cutting head after removal from a targetedanatomical region by the tool.

The bone cleaning tool 700 further includes a series of openings formedtherethrough, with each opening including at least one cutting orabrading surface or “tooth” 725 therein and/or in close proximitythereto. As best seen in FIG. 7B, a cutting surface can be positionedoutward from and/or “proud” of each opening, with various cuttingsurfaces facing towards differing orientations and/or locations, such asa first set 730 of cutting teeth that face towards a clockwiserotational cutting direction of the tool, and a second 735 set ofcutting teeth that face towards a counterclockwise rotational cuttingdirection of the tool 700. If desired, the first and second sets 730 and735 of teeth can be designed to cut similar tissues during clockwise andcounterclockwise rotation (thereby allowing the tool life to be extendedsignificantly simply by reversing the cutting direction of the tool),and/or the first and second sets of teeth can be designed to cutdifferent types and/or amounts of tissues, depending upon rotationaldirection (allowing for differential cutting techniques withoutrequiring tool exchanges and/or removal of the cutting tool from thesurgical site).

If desired, a single cutting surface can be contained within eachopening. Alternatively, one or more openings can included a plurality ofcutting surfaces, including cutting surfaces capable of cuttingdifferent tissues when the tool is rotated and/or moved in differentdirections. If desired, additional cutting surfaces could beincorporated into the upper and/or lower surfaces of each opening,including surfaces that cut tissues when the tool is advanced and/orwithdrawn along its longitudinal axis.

If desired, one or more of the cutting “teeth” can extend outward of theopenings, can be positioned within the openings, and/or could bepositioned below the openings. If desired, a single tool could includeopenings having various combinations and/or orientations of cuttingteeth, including a single tool incorporating different sized and/orshape openings and/or different sized, shaped, orientated and/orpositioned cutting surfaces relative to the openings (i.e., proud, flushand/or recessed). In addition, the cutting teeth could include cuttingsurfaces that respond or react to the speed of rotation of the tool,including cutting teeth that may deflect to extend further outwardduring high-speed rotation (i.e., due to the increased centrifugal forceon the teeth as the tool rotates), thereby providing a differential typeand/or amount of cutting due to tool rotational speed changes.

Each of the individual cutting surfaces of a given tool can assume avariety of shapes, including flat cutting surfaces as well as curvedcutting surfaces and/or more complex cutting surface shapes in twoand/or three dimensions. If desired, where multiple cutting surfaces arecontained within a single opening, these cutting surfaces could be thesame and/or different shapes and/or configurations. In a similar manner,cutting surfaces within each of the plurality of openings within a toolcould be the same and/or different configurations in different openings,if desired.

FIGS. 8A and 8B depict another alternative embodiment of a bone cleaningtool 800, in perspective line drawing and shaded formats, respectively.In this embodiment, the outer surface of the tool 800 is generallyspherical in shape, with a plurality of outwardly extending cuttingsurfaces and associated openings. During use, the tool may be rotated,turned and/or otherwise manipulated to present a variety of cuttingsurfaces towards targeted tissues, which in some embodiments may cut thetissue differentially depending upon the angle and/or speed of thepresented cutting surface(s). In a similar manner, the rotation speed ofthe tool may be varied and/or the rotation may be reversed to presentvarious other cutting surfaces to the tissues of interest. In at leastone exemplary embodiment, a plurality of reaming and/or cutting headscan be provided in a kit form, with various tools utilized to cut and/orabrade different types and manners of soft and/or hard tissues. Thereaming and/or cutting heads may contain features that facilitate theremoval of soft tissue in situ, prior to removal of the bone andpotentially preserve and/or prevent damage to remaining bone harvestsite area. These features may include textured bone cleaning tool headsurfaces including raised protrusions and/or a plurality of openingsplaced into and/or on the surface of the reaming and/or bone cleaningtool head, with one or more cutting surfaces and/or edges in at leastone area within and/or surrounding the perimeter of the openings. Forexample, an exemplary opening could include a steeply inclined cuttingsurface formed along one portion of an internal wall (which woulddesirably cut tissue in a given manner while the tool was rotated in afirst direction), and a less-steeply inclined cutting surface formedalong a second portion of the same internal wall (which would desirablycut tissue in a different manner while the tool was rotated in a seconddirection). If desired, the plurality of opening, textured bone cleaningtool head surface and/or protrusions therein may have similar ordifferent sizes, shapes, cutting edges/features and/or configurations

In other various embodiments, the bone cleaning tool head may combinethe various embodiments as described herein (not shown). For example,the bone cleaning tool head may include apertures with cutting edges inone end of the bone cleaning tool head (i.e., for soft tissue), and havereaming and/or drill bit features near the opposite end (i.e. for bonecutting or rough cuts). Alternatively, the bone cleaning tool head maycontain raised protrusions or textured surfaces in one end of the bonecleaning tool head, and have micro-curette shaped spines near theopposite end.

In at least one embodiment, the bone cleaning tool head may be utilizedto denude, decorticate and/or shape bone when operating in at least onedirection. Desirably, the shaft of the bone cleaning tool head can beplaced into a surgical rotary action hand piece and operated in adesired direction at a speed sufficient to complete the removal of softtissue from an intended bone graft and/or recipient graft site.Following the removal of the soft tissue, the direction of rotation ofthe bone cleaning tool head can then be reversed and/or otherwisealtered (i.e., increased and/or decreased in speed) and then applied tothe bone surface so as to contact and remove cortical and/or cancellousbone from the external wall of host and/or graft bone. The rotatingspines of the bone cleaning tool head can be lightly applied to the bone(which may be at a higher rate of speed, if desired) and worked in alongitudinal direction along the bone to remove cortical and/orcancellous bone, which may include removal of cortical bone until thesoft cancellous bone is visible. If desired, the spines of the bonecleaning tool head can pick-up and/or retain the cortical bone, with thebone tissue extracted as desired.

If desired, the various embodiments described herein can includefeatures that allow a user to contour bone on the graft and/or recipientgraft site. The rotating spines of the current invention can desirablybe applied to the bone and worked along the bone until the desired shapehas been achieved.

In the case of small bone grafts which have already been separated fromhost tissue, the graft may be held with a bone clamp or other similarinstrument and the invention applied to the graft as mentioned herein.

In various embodiment, the bone cleaning tool head may be changed indiameter and/or shape. Accordingly, the materials used to manufacturethe bone cleaning tool may be changed or coated with another material.Additionally, the size, shape, diameter, length and/or number of spinesmay be changed as desired.

The various headings and titles used herein are for the convenience ofthe reader, and should not be construed to limit or constrain any of thefeatures or disclosures thereunder to a specific embodiment orembodiments. It should be understood that various exemplary embodimentscould incorporate numerous combinations of the various advantages and/orfeatures described, all manner of combinations of which are contemplatedand expressly incorporated hereunder.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention are to be construed to cover boththe singular and the plural, unless otherwise indicated herein orclearly contradicted by context. The terms “comprising,” “having,”“including,” and “containing” are to be construed as open-ended terms(i.e., meaning “including, but not limited to,”) unless otherwise noted.Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., i.e., “such as”) provided herein,is intended merely to better illuminate the invention and does not posea limitation on the scope of the invention unless otherwise claimed. Nolanguage in the specification should be construed as indicating anynon-claimed element as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventor for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventor expects skilled artisans to employ such variations asappropriate, and the inventor intends for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

What is claimed:
 1. A method of preparing a graft bone during a surgicalbone graft procedure, the method comprising the steps of: providing arotary cutting tool comprising an elongated shaft and a cutting headincluding a plurality of openings therein for rotary engagement with atissue surface of the graft bone, the elongated shaft having a proximalend and a distal end and the cutting head mounted on the elongated shaftproximate to the distal end, at least one of the plurality of openingsincluding a first cutting surface incorporating a contact surface forcutting a softer tissue and a second cutting surface incorporating acontact surface for cutting a harder bony tissue, the first and secondcutting surfaces located proximate to an inner wall of the at least oneof the plurality of openings; causing the rotary cutting tool to rotatein a first direction and applying the rotary cutting tool to the tissuesurface to engage with and remove the softer tissue using the firstcutting surface; and then causing the rotary cutting tool to rotate in asecond direction and applying the rotary cutting tool to the tissuesurface to engage with and remove the harder bony tissue using thesecond cutting surface.
 2. The method of claim 1, further comprising thestep of: causing the rotary cutting tool to rotate in the seconddirection such that the second direction generally opposes the firstdirection; applying the rotary cutting tool to the tissue surface; andmoving the rotary cutting tool along the tissue surface while the rotarycutting tool rotates in the second direction to engage the secondcutting surface with a second portion of the tissue surface so as toremove the second portion of the tissue surface.
 3. The method of claim1, wherein the softer tissue comprises a soft tissue surface overlyingthe harder bony tissue.
 4. The method of claim 1, wherein the firstcutting surface incorporates a less aggressive cutting surface than thesecond cutting surface.
 5. The method of claim 1, wherein the firstcutting surface incorporates a more aggressive cutting surface than thesecond cutting surface.
 6. A method of preparing a graft bone during asurgical bone graft procedure, the method comprising the steps of:providing a rotary cutting tool comprising an elongated shaft and acutting head including a plurality of openings therein arranged forrotary engagement with a tissue surface of the graft bone, the elongatedshaft having a proximal end and a distal end and the cutting headmounted on the elongated shaft proximate to the distal end, at least oneof the plurality of openings including a first cutting surfaceincorporating a contact surface for cutting a first tissue and a secondcutting surface incorporating a contact surface for cutting a secondtissue, the first and second cutting surfaces located proximate to aninner wall of the at least one of the plurality of openings; causing therotary cutting tool to rotate in a first direction at a first rotationalspeed such that application of the rotary cutting tool to the tissuesurface causes the first cutting surface to contact with and remove thefirst tissue from the graft bone; and then causing the rotary cuttingtool to rotate in the first direction at a second rotational speed suchthat application of the rotary cutting tool to the tissue surface causesthe second cutting surface to contact with and remove the second tissuefrom the graft bone.
 7. The method of claim 6, wherein the first tissuecomprises a soft tissue surface overlying harder bony tissue.
 8. Themethod of claim 6, wherein the first cutting surface incorporates a lessaggressive cutting surface than the second cutting surface.
 9. Themethod of claim 6, wherein the first cutting surface incorporates a moreaggressive cutting surface than the second cutting surface.
 10. A methodof preparing a graft bone during a surgical bone graft procedure, themethod comprising the steps of: providing a rotary cutting toolcomprising an elongated shaft and a cutting head including a pluralityof openings therein arranged for rotary engagement with a tissue surfaceof the graft bone, the elongated shaft having a proximal end and adistal end and the cutting head mounted on the elongated shaft proximateto the distal end, at least one of the plurality of openings including afirst cutting surface incorporating a contact surface for cutting afirst softer tissue and a second cutting surface incorporating a contactsurface for cutting a second softer tissue, the first and second cuttingsurfaces located proximate to an inner surface of the at least one ofthe plurality of openings; causing the rotary cutting tool to rotate ina first direction and applying the rotary cutting tool to the tissuesurface to engage with and remove the first softer tissue using thefirst cutting surface without cutting an underlying harder bony tissueof the graft bone; and causing the rotary cutting tool to rotate in asecond direction and applying the rotary cutting tool to the tissuesurface to engage with and remove the second softer tissue using thesecond cutting surface without cutting the underlying harder bony tissueof the graft bone.